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DELSTRIGO- doravirine, lamivudine, and tenofovir disoproxil fumarate tablet, film coated


  1. Patient Information
  2. Delstrigo Is A Prescription Medicine That Is Used Without Other Hiv-1 Medicines To Treat Hiv-1 Infection In Adults:
  3. Do Not Take Delstrigo If You Take Any Of The Following Medicines:
  4. Before Treatment With Delstrigo, Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  5. Are Pregnant Or Plan To Become Pregnant. It Is Not Known If Delstrigo Can Harm Your Unborn Baby. Tell Your Doctor If You Become Pregnant During Treatment With Delstrigo.pregnancy Registry:
  6. How Should I Take Delstrigo?
  7. Delstrigo May Cause Serious Side Effects, Including:
  8. What Are The Ingredients In Delstrigo?

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV

Inform patients that severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued lamivudine or TDF and may occur with discontinuation of DELSTRIGO[

DELSTRIGO can cause serious side effects, including:
Worsening of hepatitis B virus infection (HBV).
If you have Human Immunodeficiency Virus-1 (HIV-1) and HBV infection, your HBV infection may get worse (flare-up) if you stop taking DELSTRIGO. A "flare-up" is when your HBV infection suddenly returns in a worse way than before. Your doctor will test you for HBV infection before you start treatment with DELSTRIGO.
  • Do not run out of DELSTRIGO. Refill your prescription or talk to your doctor before your DELSTRIGO is all gone.
  • Do not stop taking DELSTRIGO without first talking to your doctor.If you stop taking DELSTRIGO, your doctor will need to check your health often and do blood tests regularly for several months to check your liver. Tell your doctor about any new or unusual symptoms you may have after you stop taking DELSTRIGO.
For more information about side effects,

Delstrigo Is A Prescription Medicine That Is Used Without Other Hiv-1 Medicines To Treat Hiv-1 Infection In Adults: 

  • who have not received HIV-1 medicines in the past, or
  • to replace their current HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements.
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).DELSTRIGO contains the prescription medicines doravirine, lamivudine and tenofovir disoproxil fumarate.It is not known if DELSTRIGO is safe and effective in children under 18 years of age.

Do Not Take Delstrigo If You Take Any Of The Following Medicines: 

  • carbamazepine
  • oxcarbazepine
  • phenobarbital
  • phenytoin
  • enzalutamide
  • rifampin
  • rifapentine
  • mitotane
  • St. John's wort
Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above. If you have taken any of the medicines in the past 4 weeks, talk to your doctor or pharmacist before starting treatment with DELSTRIGO.Do not take DELSTRIGO if you have ever had an allergic reaction to lamivudine.

Before Treatment With Delstrigo, Tell Your Doctor About All Of Your Medical Conditions, Including If You: 

  • have hepatitis B virus infection
  • have kidney problems
  • have bone problems, including a history of bone fractures

Are Pregnant Or Plan To Become Pregnant. It Is Not Known If Delstrigo Can Harm Your Unborn Baby. Tell Your Doctor If You Become Pregnant During Treatment With Delstrigo.pregnancy Registry: 

There is a pregnancy registry for people who take DELSTRIGO during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take DELSTRIGO.
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
    • Two of the medicines in DELSTRIGO (lamivudine and tenofovir) can pass into your breast milk. It is not known if doravirine can pass into your breast milk.
    • Talk with your doctor about the best way to feed your baby.
  • Tell your doctor about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.
    • Some medicines interact with DELSTRIGO. Keep a list of your medicines to show your doctor and pharmacist.
    • Tell your doctor if you have taken rifabutin in the past 4 weeks.
    • You can ask your doctor or pharmacist for a list of medicines that interact with DELSTRIGO.
    • Do not start taking a new medicine without telling your doctor.Your doctor can tell you if it is safe to take DELSTRIGO with other medicines.

    How Should I Take Delstrigo? 

    • Take DELSTRIGO every day exactly as your doctor tells you to take it.
    • Take DELSTRIGO 1 time each day, at about the same time every day.
    • DELSTRIGO is usually taken by itself (without other HIV-1 medicines).
    • If you take the medicine rifabutin during treatment with DELSTRIGO, your doctor will also prescribe an additional dose of doravirine for you. You may not have enough doravirine in your blood if you take rifabutin during treatment with DELSTRIGO. Carefully follow your doctor's instructions about when to take doravirine and how much to take. This is usually 1 tablet of doravirine about 12 hours after your last dose of DELSTRIGO.
    • Take DELSTRIGO with or without food.
    • Do not change your dose or stop taking DELSTRIGO without talking to your doctor. Stay under a doctor's care when taking DELSTRIGO.
    • It is important that you do not miss or skip doses of DELSTRIGO.
    • If you miss a dose of DELSTRIGO, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses of DELSTRIGO at the same time.
    • If you have any questions, call your doctor or pharmacist.
    • If you take too much DELSTRIGO, call your doctor or go to the nearest hospital emergency room right away.
    • When your DELSTRIGO supply starts to run low, get more from your doctor or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to DELSTRIGO and become harder to treat.

    Delstrigo May Cause Serious Side Effects, Including: 

      • Store DELSTRIGO tablets at room temperature between 68 F to 77 F (20 C to 25 C).
      • Keep DELSTRIGO in the original bottle.
      • Do not take the tablets out of the bottle to store in another container, such as a pill box.
      • Keep the bottle tightly closed to protect DELSTRIGO from moisture.
      • The DELSTRIGO bottle contains desiccants to help keep your medicine dry (protect it from moisture). Keep the desiccants in the bottle.Do not eat the desiccants.
      Keep DELSTRIGO and all medicines out of the reach of children.General information about the safe and effective use of DELSTRIGO.Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use DELSTRIGO for a condition for which it was not prescribed. Do not give DELSTRIGO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about DELSTRIGO that is written for healthcare professionals.

    What Are The Ingredients In Delstrigo? 

    Active ingredients: doravirine, lamivudine, and tenofovir disoproxil fumarate.Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating contains hypromellose, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. The coated tablets are polished with carnauba wax.
    Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of
    MERCK & CO., INC.,Whitehouse Station, NJ 08889, USA
    U.S. License No. 0002
    For patent information: www.merck.com/product/patent/home.html
    The trademarks depicted herein are owned by their respective companies.
    Copyright 2018-2019 Merck Sharp & Dohme Corp., a subsidiary ofMerck & Co., Inc.
    All rights reserved.
    usppi-mk1439a-t-1909r001For more information, go to www.DELSTRIGO.com or call 1-877-888-4231.



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